DS/EN ISO 5840-3:2013 (Valid to: 31-08-2021)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques


Status:
Valid to: 31-08-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 136.50

Scope

ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.
ISO 5840-3:2013 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

Number of pages: 124

Published: 2013-06-06

Date of approval: 2013-05-14

International relationships : EN ISO 5840-3:2013 IDT ISO 5840-3:2013 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M253819

*Expected revoked date: 31-08-2021


Committees

Committee

  • CEN/TC 285
  • ISO/TC 150/SC 2/WG 1

Danish committee

DS/S-160